IEH-PRO-FMS-006 Medical Technology Program

Medical Technology Program
‫خطـة األجهزة الطبية‬
Function Facility Management and Safety (FMS)
Document Type Program
Policy Code IEH-PRO-FMS-006
Issue Date: 30/05/2014 Issue No.: 03 No. of Pages: 14

Revision Date (s): 10/05/2015 - 01/03/2018 Next Revision Date: 01/03/2019
Authority Position Name Signature
Eng. Ahmed Abdel
Prepared by Biomedical Engineering
Wahed
FMS Manager Dr. Shaimaa Zaki
Reviewed by
Group Quality Director Dr. Eman Desouky
Chief Operating & Medical Officer

Dr. Manal Assem
Approved By (COO)
Medical Technology
1. Scope:
1.1 Medical Technology Program will manage all services related to medical devices and
medical devices systems which including:
1.1.1 Inspection of all incoming medical devices before use
1.1.2 Install and/or manage the installation of all medical devices system
1.1.3 Provide a technology assessment and evaluation services on all medical devices, as
required under applicable laws
1.1.4 All medical devices are maintained in accordance with the manufacturer's
recommendations and that all equipment in each room/area is available for its
intended use
1.1.5 Investigate and log all actions taken with regard to all Events /Unusual occurrences
and hazard alerts/recall notices involving medical devices
1.1.6 Maintain a risk management program with respect to patient safety and medical
device hazards
1.1.7 Training of staff on all new technologies or initial technology installations and the
basis for ongoing management
2. Objectives
2.1 To have a medical technology program that is available for hospital staff in the provision of
clinical services.
2.2 Establish a plan for inspection, repair, maintenance and calibration of medical technology
and documenting the results.
2.3 The medical technology program shall be implemented by qualified and trained biomedical
engineers, administrative staff and technicians
3. Program Statement:
3.1 Medical Equipment Repairing :
It is the responsibility of Biomedical Department to repair the Medical Equipment at the
minimum timeframe and keep them in-operation.
3.2 Medical Equipment Preventive Maintenance(P.M):

It is the responsibility of Biomedical Department to maintain all Medical Equipment at
QQMD according to the preventive Maintenance Program up-to-date, accurate and
ongoing.
3.3 Medical Equipment Calibration:

It is the responsibility of Biomedical Department to calibrate the Medical Equipment
according to a Calibration Program up-to-date, accurate and ongoing.
3.4 Medical Equipment Daily Check :

IEH-PRO-FMS-006 Page 2 of 14
Revision Date: 01/03/2018
Next Revision Date: 01/03/2019
Medical Technology
It is responsibility of Biomedical Department and the End user to make a Daily check for the
Medical equipment.
3.5 Obsolete Medical Equipment :

It is the responsibility of the Biomedical Department to get rid of un-repairable Eq.
3.6 The selection and evaluation of Medical Equipment:(New Medical Equipment):

It is the responsibility of the Biomedical Department to implement a yearly CAPEX,Buy new
equipment /replace old equipment and supervise the processes of installation, operation
and training to provide safety and suitable machines.
3.7 Medical Equipment in Temporary Storage (ETS):

It is the responsibility of the Biomedical Department to keep Equipment in Temporary
Storage (ETS) in proper way until retrieval when they are needed.
3.8 Medical Equipment Recall:

It is the responsibility of the Biomedical Department to inform the manufacturers and
encourage them to correct the serious problem that related to the patient safety and could
cause serious health problems or death.
Recalled equipment shall be immediately removed from service until certified safe by the
appropriate service company or agency.
3.9 Medical Equipment Training and Orientation:

It is the responsibility of the Biomedical Department to make the End- User have a sufficient
understanding of the Medical Equipment in order to operate it in a safe and effective
manner
3.10 Reporting Incidents (Equipment Failures /Equipment related events-Misuse) :

It is the responsibility of the Biomedical Department to pay close attention of:
3.10.1 Equipment failures:
It is failure of the equipment to perform or function as intended.
N.B
Equipment which displaying unusual repair history or unusual incidence of injury to
patients or staff, it will be evaluated for necessary changes/replacement
3.10.2 Equipment –Related Events:

Could be from incorrect operation, damage to body structure (Misuse)
So reporting an incident to notify the involved department immediately to
avoid Equipment damaging or exposes patient/user to serious hazards
3.11 Medical Equipment Transferring :
Medical Technology
It is the End-User responsibility to monitor transferring of the Medical Equipment from

or to his/her department by implementing a ‘Transferring Form” This to avoid
missing/losing of the equipment of each department.
3.12 Emergency Procedures (Medical Equipment Safety Plan)

It is the responsibility of Biomedical Department and End-user to identify alternative
Medical equipment or solutions by Development clinical emergency procedures to
ensure patient care are not compromised. And medical equipment is well functioning,
nonstop, even in the Emergency cases
Emergency Cases are:
3.12.1 Sudden failures of the Medical Equipment.
3.12.2 Sudden Cut off of Electricity.
3.12.3 Sudden Cut off Medical Gases
A- Oxygen
B- Medical Air
C- Vacuum
D- Compressed Air
4. Inventory
4.1 All Medical Equipment are under responsibility of Biomedical Engineering Department
4.2 All Medical Equipment are inventoried into the (List of Equipment).
4.3 Each Medical equipment is brought into the facility is assigned a Equipment Code,
4.3.1 Using of the Equipment Card of Medical equipment:
 Equipment Code
 Model
 Equipment Serial Number (S.N)
 Manufacturer
4.4 The List of Equipment will contain the list of all Medical Equipment:
4.4.1 Equipment Code
4.4.2 Its Location (department assigned)
4.4.3 Equipment Name
4.4.4 Model
4.4.5 Serial Number (S.N)
4.4.6 Manufacture
4.4.7 Local Agent
4.4.8 P.M Frequency
4.4.9 P.M Date
4.4.10 P.M Responsibility (Biomedical / Companies ( in case of under warranty or contract)
4.4.11 Calibration Frequency
4.4.12 Calibration Date
Medical Technology
4.4.13 Calibration Responsibility (Biomedical / Companies (in case of under warranty or

contract.
4.5 Each Department must have a copy of its” List of Equipment”.
5. Risk Assessment:
5.1 The BMD shall conduct proactive risk assessment on periodic basis to identify medical
technology of critical nature and prepare action plans for proper maintenance
5.2 The risk assessment program shall be comprehensive to include critical medical technology
that has direct impact on the quality and safety of patient care
5.3 Risk assessment shall be based on standard life span and historical data by addressing the
risks to patients if the medical technology fails or function is interrupted
5.4 Risk assessment results shall be reported to the Facility Management and Safety (FMS)
Committee
6. Definition(s):
6.1 Repairing:
Fix faults in the Medical Equipment to keep it in Operation.
6.2 Preventive Maintenance(P.M):
Predetermined check performed to prevent a sudden failure of the Medical Equipment.
6.3 Calibration:
Is a comparison between measurements of two devices one of them of known magnitude
called “Calibrator “and the second device is the unit under test.
6.4 Calibrator:
Is a device used to calibrate other equipment and is designed to meet certain accuracy
specifications- the process of adjusting the Medical Equipment to meet those specifications
is referred to as calibration.
6.5 Daily Check:
Regular daily steps which are performed before using any equipment to confirm that it is
working in a proper way.
6.6 Out Of Order:
Medical Equipment has a failure and under the process of repairing.
6.7 Obsolete Equipment :
Medical equipment could not be repaired because of huge damage or it may have an
obsolete spare part.
6.8 Equipment in Temporary Storage (ETS):
Over capacity Equipment that are kept in a safe place (store) to be re-operated again if
it is needed again.
6.9 Recall:
An action is taken to address a problem with a medical device that violates Technical
Specifications or it may cause a risk to health or repeated failures.
Medical Technology
6.10 Misuse:
Using of the Medical equipment in an incorrect way that can cause hazards to patient
or damage to the Equipment.
6.11 List of Equipment:
A schedule contains all information about the medical equipment in the hospital.
6.12 Equipment Code:
Short Code that helps in dealing with medical equipment.
Medical Equipment is transferred temporary from one department to another.
6.14 Life Support Medical Equipment:
Any Medical Equipment failure of which may cause patient death and they are:
6.14.1 Defibrillators
6.14.2 Ventilators
6.14.3 Anesthesia
6.15 Non-Life Support Medical Equipment :

Any Therapeutic or Diagnostic equipment failure of which will not affect patient’s Life.
Example: All Medical Equipment except the above. (Life Support Equipment)
6.16 Minor Equipment
Any Movable Medical Equipment.
6.17 Major Equipment
Any Fixed Medical Equipment.
7. Procedure details:
7.1 Medical Equipment Repairing:
All medical equipment failures, safety alerts, Alarms, hazard and recalls will be
directed to the biomedical team (In the case of the call is not directed to the
Biomedical team, it must be rerouted to them). As in Work order process flow
7.1.1 Order taker receives work order with equipment failure details.
7.1.2 “Out Of Order Card” (Red) will be stick on the equipment.
7.1.3 Biomedical Eng. checks the equipment.
 If the Problem is solved,
o Equipment will enter into the service.
o Remove the “Out Of Order Card (Red)
o Write the repairing details in the work order form.
o Work order will be signed by the repairing engineer with date of
repairing.
o Work order will be signed by the receiver with date of receiving.
 If the Problem is NOT solved

o “Out Of Order Card” (Red) will be stick on the equipment
o If Equipment is in warranty or under contract:
Medical Technology
o Call its Agent Company which will report the error details in the “Service
Report”
o If Equipment is not in warranty or under contract:
o Using Service manuals to solve the problem.
 If the Problem is still not solved, within maximum 6 months:

o Equipment will be declared obsolete and will be scrapped.
7.2 Medical Equipment Repairing -- if Medical Equipment is in the warranty period or Under
Maintenance Contract:
7.2.1 Medical Equipment will be repaired by Agent
7.2.2 Medical Equipment will be maintained /calibrated by Agent. And its frequency will
be performed according to the both service manual and” Maintenance Contract
recommendation.
7.3 Medical Equipment - Neither in the Warranty Period Nor Under Contract:
Medical equipment will be repaired /maintained /calibrated by Biomedical
Engineering.
7.4 Forms of Repairing, Preventive Maintenance, Calibration, Daily Check ---etc. will be filed in
specific files according to its Unit /Department/Ward.
7.5 Medical Equipment Preventive Maintenance (P.M)&Medical Equipment Calibration:

7.5.1 Steps of the P.M/Calibration are identified from the Service Manual of each Medical
Equipment.
7.5.2 Interval (Frequency) of the P.M/Calibration is identified for each Medical
Equipment.
7.5.3 Maintenance /calibration procedures (P.M/calibration Forms) will be documented
and maintained in the Biomedical Department office.
7.5.4 P.M Card /Calibration Card will be stacked on the maintained/Calibrated equipment
contain PPM/Calibration date and PPM/Calibration due date and the signature of
engineer.
N.B
1- Next P.M & Calibration Date will be valid up till the end of the month.
2- Some Medical equipment has no calibration (N/A—Not Applicable).
7.6 Medical Equipment Daily Check

7.6.1 Daily check by Biomedical Engineer--- life support equipment.
 After performing the daily check, the form is signed by both Biomedical
Engineer and End-user.
 The End-user is responsible for keeping the daily check record in the
biomedical file.
Medical Technology
7.6.2 Daily check by the End-User---- Other Medical Equipment

 After performing the daily check, it is signed by the operator (End-user) and
monthly by Biomedical Department.
 Forms are kept in each department.
7.7 An Obsolete Medical Equipment:

7.7.1 When the equipment could not be repaired, it will be scraped and will be deleted
from the used list and added to the "Scraped list” in the “List of Equipment”.
7.7.2 An updating hardcopy of used equipment in the “List of Equipment” will be re-given
to the department after removing the scraped equipment.
7.7.3 If the Medical Equipment is Under contract :
7.7.4 “Financial Department” will be informed to stop its Maintenance Contract.
7.8 The selection and evaluation of Medical Equipment: (New Medical Equipment:
7.8.1 Implement a Yearly CAPEX for buying New Medical equipment or replace old
equipment during the year by biomedical engineering and financial department.
7.8.2 Identify the appropriate requirements (Technical Specification) by biomedical
engineering department to be sent to the purchasing department to collect offers.
7.8.3 Perform a detailed evaluation prior to purchasing by the purchasing Manager
including its standard features ,options, FDA & CE approval ,any reported history of
problems, warranty ,company reputation and after sales service , durability to select
most advanced suitable brands that comply with the required technical
specification.
7.8.4 Send offers (at least three when applicable) by purchasing Manager to the
Biomedical Manager and CMO or Medical Referent to select the best choice.
7.8.5 Identify the needed budget for their purchasing process by financial department.
7.8.6 Purchasing &Financial Ad Hoc committee is held for price negotiation to choose
from, based on both cost of spare parts, warranty, equipment consumables and
delivery time.
7.8.7 Purchasing Manager will present a financial and technical comparison for final
approval from General Manager.
7.8.8 Purchasing Order (P.O) is issued with all requirements by the Purchasing Manager
with special notes (If there is) and send it to the selected company.
7.8.9 Checking of the biomedical equipment is performed by the Biomedical Engineering
Manager on arrival.
7.8.10 Biomedical Engineering Manager examines the device and its conformity with
Purchasing Order (P.O) issued to the supplier company.
7.8.11 After examination the equipment will be
 Accept, if it confirm with specified specification in technical Study and P.O.
 Reject , if it is not comply with specified specification or P.O
Medical Technology
7.8.12 After delivery of the new equipment, supervision of the installation processes,
operation, and training is done by the agent company.
7.8.13 Biomedical Department opens a new file for the new equipment, Include Technical
specification, Technical comparison, Purchasing Order (P.O).
7.8.14 New Sheet (New Medical Equipment Sheet) is opened to follow all requirements (as
Warranty or contract, calibration certification, service and operating Manual …etc.)
for the new equipment to enter in the service.
7.8.15 New Medical equipment will not be accepted as final until the completion of
deficiencies.
7.8.16 Biomedical Engineering representative is primary Sign on GRN (Good reception
Note) with note that it will be under trial operation until complete installation and
operation.
7.8.17 After actual operation, Biomedical Manager will sign of both the validity of the
device, invoice and full training with the end user.
7.8.18 New Medical equipment is coded and inserted in the List of Equipment.
7.8.19 PM card, calibration card (If applicable) and a new work Instruction &Safety
consideration sheet are placed on the equipment as guidelines for the End-User.
7.8.20 Maintenance procedures will be developed by the “Agent Companies".
7.9 Medical Equipment Recall:

7.9.1 All notifications received are forwarded immediately to Biomedical Engineering
Department.
7.9.2 Biomedical Engineer will check the Medical equipment failure history to identify the
severity of the risk.
7.9.3 Biomedical Department will submit a report” to any/all appropriate departments
involved in using this device.
7.9.4 Recalled equipment shall be immediately removed from service until certified safe
by the appropriate service company or agency.
7.9.5 Equipment is replaced with a safe effective substitute.
7.9.6 Label the recalled equipment to prevent them from being used.
7.9.7 Inform the manufacturers and encourage them to correct the problem or focus on
the steps that the End- users can take to prevent or reduce medical device risks to
patient care and healthcare worker safety.
7.10 Medical Equipment Training and Orientation

7.10.1 Training will include:
 Basic operating procedures(Work instructions),
 Safety procedures(Hazards),
 Daily check,
 Emergency procedures if a failure occurs,
 Reporting procedures for equipment problems, failures or user errors.
Medical Technology
7.10.2 Personnel that have an equipment problem due to user errors will be retrained on
the operation and use of equipment prior to being allowed to operate equipment.
7.10.3 Biomedical Engineering Department will contact vendors of new machines to
perform training session for all concerned staff on the operation of any new
machine(s).
7.10.4 Service report (include attendance staff who had been trained) will be maintained
and kept in file.
7.11 Reporting Incidents (Equipment Failure /Equipment Related event - Misuse)

7.11.1 Order taker receives work order with equipment failure details.
7.11.2 Equipment will be checked by the engineer.
7.11.3 If Equipment related events (Misuse) it will be signed on the misuse part in the work
order and it will signed by the HOD (To see the damage before repairing).
7.11.4 An Incident Report will be submitted with detail include the cost of repairing to
both the HOD and Quality Department to investigate.

Medical equipment will be transferred from (A) to (B) Department
7.12.1 Data of the transferred equipment are written in the “Transferring Form” by (A)
Department.
7.12.2 It will be signed by the (B) Department after both checks that it is working well.
7.12.3 Equipment will be transferred.
7.12.4 When it is returned back to (A) department, “Transferring Form” will be signed by
(A) Department after check equipment operation.
7.13 Emergency Procedures (Medical Equipment Safety Plan) see attachment 11.2
7.13.1 Equipment which considered critical to patient safety (life support, critical
equipment) shall have emergency procedures in the event of malfunction or
emergency cases.
7.13.2 Each department will develop and follow specific clinical response procedures in the
event of emergency cases
7.13.3 Sudden failure of the Medical Equipment
7.13.4 Equipment will be removed from services and tagged immediately
7.13.5 Sudden cut off of electricity
7.13.6 Equipment automatically operates on Battery if it has or using E.R socket defined
as UPS
7.13.7 Sudden cut off of medical gases
7.13.8 Sudden cut of of oxygen /medical air
7.13.9 Using Oxygen Backup Cylinders automatically or by end users
7.13.10 Sudden Cut off of Vacuum
 All departments will use their Portable Suctions as a backup machine
Medical Technology
7.14 Spare Part:

7.14.1 If the spare part is available in BMD Stock:
 It will be installed directly in the Medical Eq.
(Please see attached list of spare parts that are available in BMD Stock.)
7.15 If the spare part is not available in BMD Stock;

7.15.1 It will be ordered by P.O from the Agents Co. or Local Market.
7.16 Evaluation of the Medical Technology Plan

7.16.1 The Medical Technology Plan shall be monitored and evaluated. The findings,
conclusions, recommendations, actions taken, and follow-up are reported to the
FMS Committee at least annually.
7.17 Key Performance Indicators (KPIs):

7.17.1 Percentage of compliance with PM Plan
8. Appendices:
8.1 Related Form(s):
8.1.1 N/A
8.2 Related Policy and Procedure(s):
8.2.1 N/A
9. References:
9.1 Joint Commission International Accreditation Standards for Ambulatory Care, 3rd Edition.
10. Attachment:
10.1 Check by biomedical department
Medical Technology
Attachment(s):
Check by biomedical department
Department/Equipment (by Biomedical Engineer)
Equipment that is being checked
Monitor
OR Portable Ventilator
Defibrillator
Ground Floor
Defibrillator
First Floor Defibrillator
Fiefs Floor Defibrillator
Six floor Defibrillator
1. Emergency Procedures
Sudden failures of the Medical Equipment:
Equipment will be removed from service and tagged immediately.
Life Support Medical Equipment:

No. Medical Eq. Backup Action Responsibility
1- Defibrillators Use Backup one instead End -User
Manually ventilate the patient until using of
2- Ventilator the backup one instead. End -User
Manually ventilate the patient until using of
3- Anesthesia the backup one instead. End -User
Medical Technology
Life Support Medical Equipment:

Include
Battery
No. Medical Eq. YES No Backup Action Responsibility
1 Defibrillators YES Automatic operate on Battery Automated
Automatic operate on Battery Automated
2 Ventilator YES
Automatic operate on Battery Automated
3 Anesthesia YES
Non-Life Support Medical Equipment:

No. Medical Equipment Backup Action Responsibility
Minor Equipment
1 Diode Laser Machine Use Backup one instead End -User
2 Light Source Use Backup one instead End -User

Major Equipment
No. Medical Equipment Backup Action Responsibility

11 Biometry Use Backup one instead End -User
2 Packemetery Use Backup one instead End -User
3 Autoref. Use Backup one instead End -User
4 Applination Tonometer Use Backup one instead End -User
5 Microkeratom Use Backup one instead End -User
6 Surgical Microscope Use Backup one instead End -User
7 Phaco Machine Use Backup one instead End -User
8 Vitrectomy Machine Use Backup one instead End -User
Medical Technology
1.1. Sudden Cut off of Electricity:
Non-Life Support Medical Equipment:

If Medical Equipment has battery/UPS

Must be connected to E.R wall Sockets (identify End -User
1- Minor Equipment as " UPS" )
Must be connected to E.R wall Sockets (identify Automated
2- Major Equipment as " UPS" )
If Medical Equipment has NO battery

Must be connected to E.R wall Sockets (identify
1- Minor Equipment as " UPS" ) End -User
1.2. Sudden Cut off of Medical Gases
11.2.1.1 Sudden Cut off of Oxygen /Medical Air
Life Support Medical Equipment

Automatic operate on Back up O2 Cylinder Automated
Ventilator
1-
Automatic operate on Back up O2 Cylinder Automated
Anesthesia
2-
3 Oxygen Mask Patient must be connected to O2 Cylinders End-User
Non-Life Support Medical Equipment

Constellation Medical equipment operate with Compressor Medical Air

IEH-PRO-FMS-006 Medical Technology Program

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Medical Technology Program

‫خطـة األجهزة الطبية‬

Function Facility Management and Safety (FMS)

Document Type Program

Policy Code IEH-PRO-FMS-006

Issue Date: 30/05/2014 Issue No.: 03 No. of Pages: 14

FMS Manager Dr. Shaimaa Zaki

Chief Operating & Medical Officer

3.2 Medical Equipment Preventive Maintenance(P.M):

3.3 Medical Equipment Calibration:

3.4 Medical Equipment Daily Check :

3.5 Obsolete Medical Equipment :

3.6 The selection and evaluation of Medical Equipment:(New Medical Equipment):

3.7 Medical Equipment in Temporary Storage (ETS):

3.8 Medical Equipment Recall:

3.9 Medical Equipment Training and Orientation:

3.10 Reporting Incidents (Equipment Failures /Equipment related events-Misuse) :

3.10.2 Equipment –Related Events:

3.11 Medical Equipment Transferring :

It is the End-User responsibility to monitor transferring of the Medical Equipment from

3.12 Emergency Procedures (Medical Equipment Safety Plan)

4.4.13 Calibration Responsibility (Biomedical / Companies (in case of under warranty or

4.5 Each Department must have a copy of its” List of Equipment”.

6.15 Non-Life Support Medical Equipment :

 If the Problem is NOT solved

 If the Problem is still not solved, within maximum 6 months:

7.5 Medical Equipment Preventive Maintenance (P.M)&Medical Equipment Calibration:

7.6 Medical Equipment Daily Check

7.6.2 Daily check by the End-User---- Other Medical Equipment

7.7 An Obsolete Medical Equipment:

7.9 Medical Equipment Recall:

7.10 Medical Equipment Training and Orientation

7.11 Reporting Incidents (Equipment Failure /Equipment Related event - Misuse)

7.12 Medical Equipment Transferring :

7.14 Spare Part:

7.15 If the spare part is not available in BMD Stock;

7.16 Evaluation of the Medical Technology Plan

7.17 Key Performance Indicators (KPIs):

Department/Equipment (by Biomedical Engineer)

Equipment that is being checked

First Floor Defibrillator

Fiefs Floor Defibrillator

Six floor Defibrillator

Sudden failures of the Medical Equipment:

Equipment will be removed from service and tagged immediately.

Life Support Medical Equipment:

Life Support Medical Equipment:

Non-Life Support Medical Equipment:

1 Diode Laser Machine Use Backup one instead End -User

2 Light Source Use Backup one instead End -User

No. Medical Equipment Backup Action Responsibility

1.1. Sudden Cut off of Electricity:

Non-Life Support Medical Equipment:

If Medical Equipment has battery/UPS

If Medical Equipment has NO battery

1.2. Sudden Cut off of Medical Gases

11.2.1.1 Sudden Cut off of Oxygen /Medical Air

Life Support Medical Equipment

Non-Life Support Medical Equipment

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